Class II · Moderate risk
Sermorelin Acetate
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
FDA drug recalls in 2022
Every FDA drug recall initiated in 2022, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,390 recalls, newest first.
Class II · Moderate risk
Diluent for Reconstitution Each ML contains: 1.5% Benzyl Alcohol NF
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
NAD+ Nicotinamide Adenine Dinucleotide Lyophilized powder for reconstitution
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk
Esomeprazole Magnesium Delayed-Release Capsules
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Class II · Moderate risk
Esomeprazole Magnesium Delayed-Release Capsules
Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
Class III · Low risk
Cequa (cyclosporine ophthalmic solution)
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Class III · Low risk
Methylprednisolone Tablets
Subpotent
Class II · Moderate risk
Travoprost Ophthalmic Solution
Subpotent Drug and Failed Impurities/Degradation Specifications: low out-of-specification results obtained for assay and high out-of-specification results for related substance impurities/degradation during routine stability testing.
Class III · Low risk
23.4% Sodium Chloride Injection
Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.
Class II · Moderate risk
CBD Metered Dose Inhaler
Marketed Without an Approved NDA/ANDA
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets USP
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Janumet (sitagliptin and metformin HCl)
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Class II · Moderate risk
Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class I · High risk
Suave 24-Hour Protection Aerosol Antiperspirant Powder scent
Chemical contamination: presence of benzene
Class I · High risk
The Mandalorian Hand Sanitizer
Chemical Contamination; FDA analysis found product to contain benzene
Class I · High risk
Mickey Mouse Hand Sanitizer
Chemical Contamination; FDA analysis found product to contain methanol
Class III · Low risk
Wal-Tussin DM
Incorrect/Undeclared Excipient: Product contains alcohol
Class I · High risk
Pink Pussycat SENSUAL ENHANCEMENT capsule
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk
IDArubicin Hydrochloride Injection USP 5gm/5mL
Presence of Particulate Matter: Product was found to contain silica and iron oxide
Class II · Moderate risk
Preferred Pharmaceuticals
Out of specification results observed in dissolution during long term stability testing.